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临床试验/NCT07451964
NCT07451964已完成不适用

The Role of Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants

Ain Shams University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
duration of mechanical ventilation , length of hospital stay and mortality

研究概览

简要总结

70 Neonates in neonatal intensive care unit , ain shams university , children hospital

详细描述

preterms less than 34 weeks gestational age , with moderate to severe respiratory distress syndrome , available maternal milk and delivered by cesarean section

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
0 Hours 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age less than 34 weeks
  • Patients with moderate to severe respiratory distress syndrome on invasive mechanical ventilation in the 1st 3 days of life
  • Available maternal breast milk
  • Patients delivered by caesarean section

排除标准

  • Patients with no available maternal breast milk
  • Preterms who had a surgical procedure
  • Patients with inborn error of metabolism
  • Patients with major congenital anomalies
  • Patients with hypoxic ischemic enceohalopathy
  • Patients delivered by vaginal delivery

研究组 & 干预措施

maternal milk oral care group

Active Comparator

干预措施: oral care with maternal milk (Other)

sodium bicarbonate oral care group

Placebo Comparator

干预措施: oral care with sodium bicarbonate (Other)

结局指标

主要结局

duration of mechanical ventilation , length of hospital stay and mortality

时间窗: 6 months

次要结局

  • incidence of ventilator associated pneumonia , late onset sepsis and necrotizing enterocolitis(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Youssef

lecturer of pediatrics

Ain Shams University

研究点 (1)

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